pH-weighted MRI in Multiple Sclerosis: A Surrogate Marker of Tissue Metabolic Stress

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: MRI Scan

• Registration Number: NCT03028675
• Lead Sponsor: NYU Langone Health

Brief Summary

Twenty subjects (10 patients and 10 age-matched control volunteers) will be recruited for this study. MRI scans will take place on a 3T MRI Scanner (Skyra or Prisma, Siemens Medical Solutions) located at The NYU Center for Biomedical Imaging. MRI scans will consist of a 1-hour brain scan for both patients and controls. In the first 6 months of the study, investigators will develop and test a uMT-based APT imaging for brain tissue pH measurement and use a hypercapnia paradigm to validate the tissue pH changes between breathing room air and 5% CO2 (by increasing tissue acidity) inhalation. With implementation of hypercapnia MRI, pH-weighted imaging will be validated for its robustness and reproducibility.

Detailed Description

The contrast agent (Gd-DTPA, Gadavist) will be injected intravenously (IV) in the arm (patients only). The IV will be inserted by qualified medical professional at CBI. This contrast agent will be standard dose in accordance with its FDA approved labeling and dosing. Controls will NOT be administered the contrast agent.

Study Timeline

• Study First Submitted: 2017-01-19
• Study First Submitted QC: 2017-01-19
• Study First Posted: 2017-01-23
• Study Start: 2017-05-01
• Primary Completion: 2018-08-10
• Study Completion: 2018-08-10
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-09
• Last Update Posted: 2020-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• Healthy male or female non-MS control volunteers

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Exclusion Criteria

• Medically unstable or with cardiac, pulmonary, hematological, renal, or hepatic dysfunction.

• Current or past DSM-IV diagnosis of major depression, bipolar and psychotic disorders.

• Contraindications for MRI, including

• Intracranial clips

• Metal implants

• External metallic devices/objects/clips within 10mm of the head

• Suspected or confirmed metal in the eyes (history of welding or similar activity)

• Claustrophobia

• Cardiac pacemaker or pacing wires

• Pregnancy - Pregnancy tests will be offered to women of childbearing age at no cost to the subject

• History of moderate to severe head injury, stroke, and seizures.

• Alcoholism or drug dependency.

• Renal or liver disease as this may cause concerns related to Gd-DTPA contrast agent.

  • Allergy to the contrast agent Gadolinium
  • Relapses or steroid therapy in patient at or in the month preceding the study
  • Patients only

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Multiple Sclerosis	MRI Scan	-
Healthy Volunteer	MRI Scan	10 age-matched control volunteers

Primary Outcome Measures

Name	Time	Method
pH measurements	20 Minutes	The pH will be estimated based on the calibration methods of quantification of exchange as a function of saturation time (QUEST)32 and its ratiometric analysis (QUESTRA) 33.

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States